GOSURAN 2.5 mg Tabletki powlekane

Treść ulotki

1. Gosuran 2.5 mg film-coated tablets
   1. What is Gosuran and what is it used for
   2. What you need to know before taking Gosuran
2. Gosuran contains lactose (milk sugar). If your doctor has diagnosed you with
   1. How to take Gosuran
   2. Possible side effects
   3. How to store Gosuran
   4. Contents of the pack and other information

Gosuran 2.5 mg film-coated tablets

Letrozole
Generic medicine
Read this leaflet carefully before you start taking this medicine because
it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even
if they have the same symptoms as you, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Gosuranis and what it is used for
• 2. What you need to know before you take Gosuran
• 3. How to take Gosuran
• 4. Possible side effects
• 5. How to store Gosuran
• 6. Contents of the pack and other information

1. What is Gosuran and what is it used for

Gosuran contains an active substance called letrozole. It belongs to a group of
medicines called aromatase inhibitors. It is a hormonal (or “endocrine”) treatment for
breast cancer. The growth of breast cancer is frequently stimulated
by estrogens, which are female sex hormones. Gosuran reduces the amount of estrogens
by blocking an enzyme (“aromatase”) that is involved in the production of estrogens and
therefore can block the growth of breast tumors that need estrogens to
grow. As a consequence, the growth of tumor cells is slowed down or stopped and/or their
spread to other parts of the body.

What is Gosuran used for
Gosuran is used for the treatment of breast cancer in women in menopause
i.e. who no longer have menstrual cycles.
It is used to prevent the recurrence of breast cancer. It can be used as
a first treatment before breast surgery in cases where immediate surgery
is not possible or as a first treatment after breast surgery or
after five years of tamoxifen treatment. Gosuran is also used to prevent
the spread of breast cancer to other parts of the body in patients with breast cancer
in an advanced stage.
If you have any questions about how Gosuran works or why this medicine has been prescribed
to you, please ask your doctor.

2. What you need to know before taking Gosuran

Follow all of your doctor's instructions carefully. They may differ from the

Do not take Gosuran
if you are allergic to letrozole or any of the other ingredients of this medicine
(listed in section 6);
if you still have your menstrual cycle, i.e. if you have not yet reached menopause;
if you are pregnant;
if you are breastfeeding.
If any of these conditions apply to you, do not take this medicine and tell your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Gosuran
if you have a severe kidney disease
if you have a severe liver disease
if you have a history of thinning or fragility of the bones (osteoporosis) or bone fractures
(see also “Monitoring treatment with Gosuran” in section 3)
If any of these conditions apply to you, tell your doctor. This will be taken into
consideration by your doctor during treatment with Gosuran.
Letrozole can cause inflammation of the tendons or tendon injury (see section 4). At the
first sign of tendon pain or swelling, rest the painful area and contact your doctor.

Children and adolescents (under 18 years of age)
Children and adolescents should not use this medicine.

Elderly (65 years of age and over)
Women aged 65 years and over can use this medicine at the same dose
as prescribed for adult women.

Other medicines and Gosuran
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.

Pregnancy, breastfeeding and fertility

• You must only take Gosuran when you have entered menopause. However, your doctor will discuss with you the need to use an effective contraceptive method as you could potentially be pregnant during treatment with Gosuran.
• You must not take Gosuran if you are pregnant or breastfeeding as it may be harmful to the baby.

Driving and operating machinery
If you feel dizzy, tired, sleepy or generally unwell, do not drive
or use machinery until you feel normal again.

Gosuran contains lactose

Gosuran contains lactose (milk sugar). If your doctor has diagnosed you with

an intolerance to certain sugars, contact them before taking this medicine.

Gosuran contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially ‘sodium-free’.

For athletes: the use of the drug without therapeutic necessity constitutes doping and
may still result in a positive anti-doping test.

3. How to take Gosuran

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor, pharmacist or nurse.
The recommended dose is one Gosuran tablet to be taken once a day.
Taking Gosuran every day at the same time will help you remember when to take the
tablet.

How to take Gosuran
The tablet can be taken with or without food and must be swallowed whole with a
glass of water or another beverage.

How long to take Gosuran
Continue to take Gosuran every day for the duration that your doctor has told you. You may
need to take it for several months or even for several years. If you have questions about
how long to take Gosuran, talk to your doctor.

Monitoring during treatment with Gosuran
You must take this medicine under close medical supervision. The doctor will check
your health status regularly to verify that the treatment has the desired effect.
Gosuran may cause fragility or loss of bone mass (osteoporosis) due to the decrease of
estrogens in the body. The doctor may decide to perform a bone density measurement
(a way to check for osteoporosis) before, during and after treatment.

If you take more Gosuran than you should
If you have taken too much Gosuran, or if someone else has accidentally taken your
tablets, contact your doctor or hospital immediately for advice. Show them the
pack of tablets. Medical treatment may be necessary.

If you forget to take Gosuran

• If you realise you have forgotten your tablet when it is almost time to take the next dose (for example within 2 or 3 hours before the next dose), do not take the forgotten dose but take the next dose at the usual time.
• Otherwise take the dose as soon as you remember, and then take the next tablet at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Gosuran
Do not stop taking Gosuran unless your doctor tells you to do so. See
also above the paragraph “How long to take Gosuran”.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most side effects are mild to moderate and usually disappear after a period of treatment between a few days and a few weeks.
Some of these side effects, such as hot flushes, hair loss, or vaginal bleeding, may be caused by a lack of estrogen in the body.
Do not be concerned by this list of possible side effects; it is possible that none of them will affect you.

Some side effects may be serious:
Uncommon(may affect up to 1 in 100 people):

• Weakness, paralysis, or loss of sensation in any other part of the body (especially arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (symptom of a brain condition, such as stroke).
• Sudden chest pain with a feeling of tightness (symptom of a heart condition).
• Swelling and redness along a vein that is extremely sensitive and also painful to the touch.
• High fever, chills, or mouth ulcers caused by infections (lack of white blood cells).
• Severe and persistent blurred vision.
• Inflammation of a tendon or tendinitis (connective tissue that connects muscles to bones).

Rare(may affect up to 1 in 1,000):

• Difficulty breathing, chest pain, fainting, rapid heartbeat,

bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (symptoms of a possible blood clot formation).

• Rupture of a tendon (connective tissue that connects muscles to bones).

If any of these effects occur, tell your doctor immediately.
You should immediately inform your doctor if you experience any of the following symptoms during treatment with Gosuran:

• Swelling mainly of the face and throat (signs of an allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, dark urine (signs of hepatitis).
• Skin rash, reddened skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin conditions).

Some side effects are very common(may affect more than 10 people in 100):
Hot flushes;
Increased cholesterol levels (hypercholesterolemia);
Fatigue;
Increased sweating;
Bone and joint pain (arthralgia).
If any of these effects occur severely, tell your doctor immediately.

Some side effects are common(may affect up to 1 in 10 people):
Skin rash;
Headache;
Dizziness;
General feeling of discomfort (malaise);
Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea;
Increased or decreased appetite;
Muscle pain;
Fragility or loss of bone mass (osteoporosis), which in some cases leads to bone fractures (see also “Monitoring during treatment with Gosuran in paragraph 3);
Swelling of the arms, hands, feet, and ankles (edema);
Depression;
Weight gain;
Hair loss;
Increased blood pressure (hypertension);
Abdominal pain;
Dry skin;
Vaginal bleeding;
Palpitations, rapid heartbeat (tachycardia)
Joint stiffness (arthritis);
Chest pain
If any of these effects occur severely, tell your doctor immediately.

Other side effects are uncommon(may affect up to 1 in 100 people):
Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, insomnia;
Pain or burning sensation in the hands or wrist (carpal tunnel syndrome);
Impaired sensation, especially to the touch;
Eye disorders such as blurred vision, eye irritation;
Skin conditions such as itching (urticaria);
Vaginal discharge or dryness;
Breast pain;
Fever;
Thirst, taste disturbances, dry mouth;
Dryness of mucous membranes;
Weight loss;
Urinary tract infections, increased frequency of urination;
Cough;
Increased levels of liver enzymes;
Inflammation of a tendon or tendinitis (connective tissues that connect muscles to bones)
Yellowing of the skin and eyes
Elevated levels in the blood of bilirubin (a breakdown product of red blood cells)

Side effects with unknown frequency(frequency cannot be estimated based on available data)
Trigger finger, a condition in which one of the fingers of the hand remains locked in a bent position.
If any of these effects occur severely, tell your doctor immediately.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. How to store Gosuran

Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister
after Exp. The expiry date refers to the last day of the month.
Do not use a package that is damaged or shows signs of tampering.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Gosuran contains
The active ingredient is letrozole. Each film-coated tablet contains 2.5 mg of
letrozole.
The other ingredients are:
Tablet core: Lactose, Microcrystalline cellulose, Corn starch, Sodium starch
glycolate, Anhydrous colloidal silica, Magnesium stearate.
Tablet coating: Opadry yellow 02B38014 [Titanium dioxide (E171), Yellow iron oxide
(E172), Macrogol 4000, Red iron oxide (E172), Talc, Hypromellose (E464)].

Description of the appearance of Gosuran and contents of the pack
Gosuran is in the form of film-coated tablets, yellow in colour, round and biconvex
on both sides.
Gosuran is available in packs of 30 film-coated tablets in blister packs
PVC/PE/PVDC/aluminium.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Genetic S.p.A. Via Della Monica n. 26 - 84083 Castel San Giorgio (SA), Italy

Manufacturer
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA), Italy